Testimony before the Maryland House Health and Government Operations Committee by Richard M. Doerflinger

Date: 03/12/2003

March 12, 2003

I am Richard M. Doerflinger, Deputy Director of the Secretariat for Pro-Life Activities at the U.S. Conference of Catholic Bishops in Washington D.C. I also serve as Adjunct Fellow in Bioethics and Public Policy at the National Catholic Bioethics Center in Boston. I am a Maryland resident, having lived here (in Mount Rainier, then in Silver Spring) for 22 years.

I have been asked by the Maryland Catholic Conference to present testimony today on House Bill 482, on “Stem Cell Research.” I am familiar with the bill because similar language is being marketed simultaneously in various states by certain elements of the biotechnology industry.

Regarding any bill it is a good idea to ask why it is needed. What does it approve or legalize that is not already being done legally without the bill’s enactment? After all, in American law everything is allowed unless it is expressly prohibited. So what is currently illegal, or at least legally or morally controversial, that needs to receive this legislative endorsement?

What HB 482 is not needed for

This bill is certainly not needed in order to allow adult stem cell research, which is completely legal and eligible for federal funding. Nor is it needed in order to allow the use of fetal tissue (including “embryonic germ cells” harvested from unborn children who are aborted at around 8 weeks of gestation). Such research is not only legal, but is currently conducted at Johns Hopkins University and (with certain conditions) is also eligible for federal funding. Nor is it even needed in order to allow use of embryonic stem cells obtained by destroying one-week-old human embryos who are considered to be “in excess of clinical need” donated at fertility clinics. Such research is legal in Maryland and most other states, and even some aspects of this research (i.e., research on stem cell lines that were derived from embryos before August 9, 2001) are eligible for federal funding. And the bill is not needed to set legal limits on the selling of “embryonic or cadaveric fetal tissue,” since exactly these same limits have already been part of federal law for a decade (and incidentally, have shown themselves to be inadequate and ineffectual). See 42 USC 289g-2.

What HB 482 approves

The central purpose of this bill, then, must be to approve that part of “stem cell research” that is either illegal, or so widely condemned that researchers might fear to pursue it without the legislature’s seal of approval. If the legislature approves this bill, it will do so to ensure that the following is conducted in the state of Maryland:

1. Research in which human embryos are specially created by in vitro fertilization solely in order to be destroyed for research purposes. A program of this kind was begun at a fertility clinic in Norfolk, Virginia in 2001, but was discontinued after it provoked nearly universal moral outrage from lawmakers and others. Even to many people who accept the idea of research on already existing “spare” embryos who may otherwise be discarded, the idea of creating early human lives solely to destroy them takes a giant step toward treating life as a mere instrument. A Maryland researcher may well want to have the advance approval of the state legislature before beginning such a project here.

2. Fetal tissue research that violates the ethical standards required for federally funded research. If it did not go beyond the federal funding standards it would have no need of official encouragement from the state. This could include projects in which:

– Researchers desiring fetal tissue perform the abortions themselves, or introduce changes in the timing or method of abortion to produce more usable tissue;

– Women are persuaded to have abortions precisely in order to provide transplant tissue for themselves or their loved ones.

– Women are encouraged to become pregnant so that such abortions can be performed in order to obtain fetal tissue for themselves or their loved ones.

3. Research using “somatic cell nuclear transplantation” (cloning) to produce human embryos and fetuses and born children as sources of cells and tissues. This sounds like a nightmarish science fiction scenario, but it is exactly what the bill says: “The General Assembly declares that it is the policy of the state that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation, shall be allowed.” The idea of using cloning to mass-produce and harvest human embryos as nothing more than agricultural products is horrific enough (though it is not currently illegal in the state of Maryland). The idea of extending this into the “farming” of fetal and newborn humans for spare parts, however, is the research area that most needs legislative endorsement if scientists are to have the nerve to pursue it.

Technically such research does not seem to be illegal now – that is, Maryland has no law against any kind of human cloning, and effectively no limits on abortion. And as long as parental consent is obtained, and the cell harvesting is not harmful to the child, there is no law against cloning and delivering a child solely to obtain his or her bone marrow stem cells to treat the adult whose genetic “copy” the child was created to be. But understandably, researchers will not pursue these avenues without official approval, because almost everyone on earth would see them as morally monstrous.

Why bills like HB 482 are being recommended to state legislatures

The language of this bill is no accident, at least from the viewpoint of outside groups supporting it.. A similar bill (SB 1909, AB 2840) was considered in New Jersey this year – it banned “human cloning,” but then said that one is not guilty of “cloning” unless one develops the cloned human through the embryonic, fetal and newborn stages to produce a human “individual.” The bill actually was approved by one chamber of the legislature, then ultimately withdrawn when legislators finally realized what it does. In New York a bill (A. 6249) has been introduced to allow human cloning, and the gestating of cloned embryos through the fetal stage, as long as this is not done for the purpose of producing a live birth.

Why is this being proposed now? It is done because certain interests in the biotechnology industry, fixated on the pursuit of human cloning for biomedical research, are afraid that their original model for “therapeutic cloning” may not work. The original idea was to use cloning to produce one-week-old embryos, who would then be destroyed for their “embryonic stem cells” which will be a perfect genetic match to the patient who donated genetic material for the cloning procedure. But now problems have emerged.

It turns out that “therapeutic cloning” is not working well, even in animals. Embryonic stem cells are too difficult to maintain, too uncontrollable, too likely to turn into lethal tumors in animals’ bodies. There are only two animal studies suggesting therapeutic benefits from cells that originated from cloning. One, designed to provide new kidney tissue, required gestating the cloned cow embryo in a uterus and then aborting it to obtain fetal kidney tissue (Lanza et al., 20 Nature Biotechnology 689-96, July 2002). The other, designed to correct a genetically-based immune deficiency, required taking the new mouse (produced by cloning and genetic modification) to the newborn stage and harvesting its adult stem cells to treat the original mouse (Rideout et al., 109 Cell 17-27, April 5, 2002). These new state bills on cloning are designed to keep researchers’ options open, to make it possible to transfer these animal models to human use.

This means, of course, that in approving this bill Maryland would be marking out a path that is rejected by the vast majority of Americans, and apparently by every single member of Congress. For there is no member of Congress who supports allowing cloned embryos to be placed in a womb and gestated to the fetal or newborn stage (called by some “reproductive cloning”). Some members of Congress, including some of the Maryland congressional delegation, say they want to allow use of cloning to make embryos who will be destroyed for their stem cells at an early stage in the laboratory – but the introduction of bills like these illustrates that the research community is already abandoning that stance and is moving on to the next step.

Ethical limits?

Doesn’t the bill prevent these horrors by its call for attention to ethical limits? No, it does not. There is vague talk of “consideration of the ethical concerns regarding this research,” but no actual limits. Surely no court would find that the legislature, having officially approved cloning to produce embryos, fetuses and newborns, intends to have this clear mandate overridden by someone’s “ethical concerns” after the fact. And the bill speaks of approval by an Institutional Review Board, but provides no standards by which the IRB could judge an experiment. Usually, in approving even privately funded research, IRBs follow the standards for federally funded research by default. That cannot be done here, because research that involves doing abortions to obtain fetal tissue, destroying embryos for their stem cells, and performing human cloning is completely ineligible for federal funding. So there are no standards. The IRBs will have to fly us into the Brave New World of cloning and body farming by the seat of their pants.

In so doing, the IRBs would be able to glean the following ethical guidance from the language of the bill itself:

– “Stem cell research could lead to unprecedented treatments and potential cures” for a wide array of diseases. (Incidentally, the truth of this statement is highly questionable in the case of embryonic stem cell research and “therapeutic cloning,” neither of which is anywhere near providing any treatment for humans; the statement about producing cures would be true of many aspects of adult stem cell research, but that is already legal and federally funded and in no need of help from this bill.)

– “The United States and the State of Maryland have historically fostered open scientific inquiry.” (This is a half-truth. Our federal and state governments have insisted that scientific inquiry not be pursued if it will mistreat human subjects. “Historically,” there have been lapses in which the lust for medical progress was allowed to outweigh ethical concerns, but these are the darkest pages of our national history. Maryland, in fact, has been in the forefront of states that insist on clear ethical and legal limits to medical research, and its courts have found that researchers can be sued for negligence when they give insufficient attention to the safety and well-being of children who are too young to consent to research. See Grimes v. Kennedy Krieger Institute, 782 A.2d 807 (Md. 2001). Incidentally, Maryland’s highest court found in this decision that the IRB at Johns Hopkins University had “abdicated” its responsibility to protect children from research risks, and had shown that it “was willing to aid researchers in getting around federal regulations designed to protect children used as subjects in nontherapeutic research.” No one who has read this decision will want to entrust all ethically controversial research decisions solely to IRBs).

– Maryland’s biotechnology industry is a gold mine for the state, and this situation would be endangered by “limitations” on stem cell research.

– Therefore, “public policy on stem cell research must balance ethical and medical considerations.” This statement of principle sounds nice and moderate, until one gives it a moment’s thought. Since the Nuremberg Code, society has insisted that the lure of medical progress must never be misused to outweigh ethics: “Concern for the interests of the subject must always prevail over the interest of science and society” (World Medical Association, Declaration of Helsinki (1975), I.5). Or as a survivor of Dr. Josef Mengele’s notorious “twin” experiments has said: “Human dignity and human life are more important than any advance in science or medicine” (Eva Mozes-Kor, quoted in A. Caplan, When Medicine Went Mad (1992), p. 7).

If researchers are to “balance” ethics and medicine, that means one can pursue even research that one knows is unethical — if the potential medical benefit is great enough. The researchers who conducted the Tuskegee syphilis experiment on African-American men, who deliberately infected retarded children with the hepatitis virus at the Willowbrook home, who approved the Cold War radiation experiments on unsuspecting American civilians, who allowed children to be exposed to lead poisoning in the research condemned two years ago by the Maryland Court of Appeals – these researchers “balanced” ethics and progress, and “progress” won. I urge the state of Maryland not to pursue such “balance.”

Finally, a word about the bill’s attempt to ban the selling of fetal organs and tissues. I’m sure this part of the bill is well-meant, but we know in advance it will be ineffectual. It tracks the language of a federal ban that has been in place since 1993: Such tissues and organs may not be given for “valuable consideration,” but a service fee for obtaining the tissue, shipping and handling, etc. is allowed. Under this language, fetal tissue distributors have been able to advertise the availability of various fetal organs and tissues for pay, publish “price lists” (see attached), and in brief do everything involved in selling body parts – as long as they call it a “service fee.” If Maryland wants to prepare legislation to prevent such abuse, that may be a laudable idea – but we know this language is not the way to do it.

Conclusion

My testimony will sound largely negative – and it is negative regarding this bill, which is a moral and medical horror. But I want to end with a message of hope. In recent years, enormously promising new treatments have begun to emerge from medical research. In clinical trials, patients have been successfully treated for Parkinson’s disease, sickle-cell anemia, thalassemia, Type I diabetes, severe combined immune deficiency, corneal damage, heart disease, bone and cartilage injury, and so on. Early trials in treating patients with chronic spinal cord injury have shown progress in regaining sensation and movement. All these trials used adult stem cells, other adult cells obtained ethically, or sources such as umbilical cord blood. Some of this progress has even come from researchers in Maryland. No treatment now in trials, or on the horizon, comes from embryonic stem cells or from so-called “therapeutic cloning.” By focusing on these most controversial and most speculative approaches, our resources and attention may well be diverted away from the promising treatments now on the brink of helping millions of patients – and we will actually slow down the medical progress that patients deserve.

We need not set aside human dignity, or “balance” ethics against the desire for progress – a balancing act in which ethics so often seems to lose. We can fully respect and promote sound ethics and promising medicine together, for there is no conflict between them. I urge the committee to begin this journey to ethically responsible medical progress by defeating HB 482.

NOTE: As presented to the committee this testimony included an attachment, a “Fee for Services Schedule” distributed in 1999 by a tissue procurement company in Illinois called Opening Lines. The schedule lists a long series of fetal organs of various types and stages, with prices (e.g., “Eyes (>8 weeks)